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临床试验/NCT00581685
NCT00581685已完成3 期

Does Optimal Pain Control With Pregabalin and Celecoxib Predict Improved Function After Total Hip Arthroplasty?

Sunnybrook Health Sciences Centre0 个研究点目标入组 31 人开始时间: 2008年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
31
主要终点
Physical function

研究概览

简要总结

Despite the development of new pain medications, the prevalence of persistent postoperative pain (for more than three to six months) remains alarmingly high. Chronic pain and reduced function after surgery are of great concern since they have a significant impact on a patient's quality of life and are costly to society in terms of longer hospital stays and lost work days. An important risk factor for chronic pain and reduced function after surgery is the amount of pain patients experience immediately after surgery which is highly influenced by the amount of pain patients have preoperatively. For many patients, longstanding pain prior to surgery is common and thus can compromise the outcome of the procedure. Therefore, the aim of this study is to reduce the amount of pain patients have before they undergo surgery by administering a novel pain-relieving regimen in the weeks before surgery. Crucially, this treatment will be continued for three weeks after surgery to reduce pain that arises from the surgical trauma. The novel regimen will include a non-steroidal anti-inflammatory (celecoxib) and the alpha2 delta ligand, pregabalin. This drug combination will provide the best opportunity to target several key sites in the pain pathway. This regimen will be tested in patients with pain related to osteoarthritis and who are undergoing orthopedic (hip) surgery because chronic preoperative pain is common in these patients and is the main reason for undergoing surgery. The goal of this research proposal is to adequately manage pain before and after surgery in order to improve function weeks after surgery. If controlling pain in this way does lead to improved long term postoperative function the findings from this study may lead to the development of a standardized regimen. This is highly relevant not only for orthopedic procedures but following other common surgical procedures which would be of great benefit to patients and the entire healthcare system.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Provision of informed consent
  • American Society of Anesthesiologists physical status I-III
  • Average daily VAS ≥ 4
  • Aged 18 - 75 years
  • Male or female
  • Scheduled for total hip arthroplasty (THA).

排除标准

  • Allergy to study medications or local anesthetics
  • History of drug or alcohol abuse
  • Patients with chronic pain on slow-release preparations of opioid (>30mg morphine equivalent per day)
  • Patients with rheumatoid arthritis
  • Patients with psychiatric disorders
  • Patients unable or unwilling to use Patient Controlled Analgesia (PCA).
  • Diabetic patients or those with impaired renal function (Creatinine > 55)
  • Obese patients (i.e. BMI > 40).

研究组 & 干预措施

2

Placebo Comparator

Prospective, single center, randomized, double-blinded, placebo controlled study

干预措施: Pregabalin, Celecoxib (Drug)

结局指标

主要结局

Physical function

时间窗: 6 weeks postop

次要结局

  • Pain(Pre and postoperatively (up to 6 weeks))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Colin McCartney

Staff Anesthesiologist

Sunnybrook Health Sciences Centre

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